MSD Quality Assurance Specialist 

Vietnam, Ho Chi Minh City 

660738057

Job Description

As a Quality Assurance Specialist/ In-Market Quality, you will have the following key responsibilities:

• Monitor to ensure regulations pertaining to Quality and Compliance for importation and warehouse operation, including goods receipt, storage, dispatching, and delivery at the warehouse (e.g., GSP guidelines and Vietnam regulatory requirements, where applicable) are fulfilled as per Company operation model.
• When required, work for a chief pharmacist's delegate tasks, including the approval for goods receipt and dispatching products at our company warehouse(s), and monitor the repacking/ redressing operation performed by following relevant our company SOPs requirements in coordination with Manufacturing Division principles.
• Co-operate with all related departments to develop, implement, and maintain GxP SOPs/ Work Instructions that comply with GSP requirements, Vietnamese regulations (where applicable), and related Policies / SOPs of our company Manufacturing Division. Where applicable, ensure adherence to Manufacturing Division QMS and provide local feedback to the manager.
• Monitor the implementation of the QMS established in Vietnam, take appropriate corrective and preventive action for deviations, and improve the QMS and/or Processes when necessary.
• Generates and secures QMS IMQ VN documents and records and is responsible for quality oversight of GxP documentation to comply with Global Manufacturing Division QMS requirements and local regulation requirements within our company.
• Support the execution of the Test on Importation (TOI) per Vietnam regulation requirements, including preparing the TOI documentation, following up to obtain the testing results in a timely manner, and tracking the expense of the TOI testing fee.
• Support to prepare for Health Authority (HA) interactions and notifications regarding Quality and Supply issues and local market action execution.
• Work as a Self-Inspection (SI) Auditor to perform self-inspection and/or supplier/ customer audit. Provide Responses and support to develop Corrective and Preventive Actions (CAPAs) to address SI/ Audit observation(s).
• When required, support to perform the due diligence and/or local quality assessment to evaluate the compliance level of customers/suppliers' quality system compared with Vietnam regulation and our company quality requirements and their operational performance for our company.
• Monitor Management of Deviation / CAPA approached quality events and/or Self-inspection / global Audit /Health authorities Inspection …, including tracking CAPA status.
• Support stakeholders in initiating and managing the change proposal relating to GxP requirements and/or product quality impact per change control procedure. Responsible for quality oversight to ensure the identified change action is completed as requested.
• From a quality perspective, review and monitor the qualified execution, including installation qualification, operation, and performance qualification for the warehouse’s temperature/ humidity or GxP-related equipment and system/application.
• Support to qualify equipment and packaging used for temperature-sensitive products and quality oversight for domestic transportation.

• Have accurate problem-solving skills based on science, facts, data, and understanding of the Vietnam regulatory requirements (where applicable for the pharmaceutical industry); must be able to apply sound risk management.
• Possessing comprehensive knowledge and experience with Quality Management Systems, along with a thorough understanding of relevant Vietnam regulatory requirements.
• Have experience in quality oversight of warehousing operation and distribution to develop new GxP SOPs based on global policy / SOPs and local regulation (where applicable).
• Have expertise and experience in handling Change Control, Deviation management, Root cause analysis, Developing and Managing CAPA plans, preparing for health authority GSP or GDP inspections, and conducting internal /external audits.
• Have strong demonstrated interpersonal, communication, negotiation, persuasion, and leadership skills in dealing with internal stakeholders.
• Fluently English in writing and speaking.

Desired Experience / Education

• Have expertise and experience in performing Self-Inspection (SI) and/or supplier/ customer audit. Provide Responses and support to develop Corrective and Preventive Actions (CAPAs) to address SI/ Audit observation(s). A licensed Lead auditor certification is a plus.
• Have expertise and experience in the validation/ qualification processes for equipment/systems and warehouse temperature/ humidity mapping studies.
• Have knowledge of Pharmaceutical Importation, including experience in executing Tests on Importation requirements for Distribution, Logistics, or Regulatory Affairs for product registration in Vietnam.
• Must have good collaboration skills with team and internal/external stakeholders. Proficient in stakeholder and change management with appropriate communication and cooperation skills.

QUALIFICATIONS, EXPERIENCE & COMPETENCIES

• Bachelor’s degree in pharmacy
• Locally registered pharmacist with a valid registered pharmacist license for medicinal including toxic and vaccine importation in Vietnam.
• With at least 5 years of experience in the pharmaceutical industry, specializing in quality assurance, control, systems, and audits.
• Have good enough knowledge of Vietnam GSP, local regulation (where applicable), and international regulation (e.g PIC/S, GDP, and GMP)

Current Contingent Workers apply

Not Applicable

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.